CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE
FDA premarket approval P880082/S018 · decided 1995-09-28
Approval details
- PMA number
- P880082
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE
- Generic name
- intraocular lens
- Applicant
- Eyetech, LLC
- Date received
- 1995-06-14
- Decision date
- 1995-09-28
- Days to decision
- 106 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Oakdale, MN
- Statement
- APPROVAL FOR THE USE OF A NEW CLEANING AGENT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EPISCLERAL VENOUS PRESSURE (K843354) | Eyetech, LLC | 1984-11-19 |